Background: Recent changes to regulatory guidance in the US and Europe have complicated oversight of secondary research by rendering most uses of de-identified data exempt from human subjects oversight. To identify the implications of such guidelines for harms to participants and communities, this paper explores the secondary uses of one de-identified DNA sample collection with limited oversight: the Human Genome Diversity Project (HGDP)-Centre d'Etude du Polymorphisme Humain, Fondation Jean Dausset (CEPH) Human Genome Diversity Panel. Methods: Using a combination of keyword (...) and cited reference search, we identified English-language scientific articles published between 2002 and 2009 that reported analysis of HGDP Diversity Panel samples and/or data. We then reviewed each article to identify the specific research use to which the samples and/or data was applied. Secondary uses were categorized according to the type and kind of research supported by the collection. Results: A wide variety of secondary uses were identified from 148 peer-reviewed articles. While the vast majority of these uses were consistent with the original intent of the collection, a minority of published reports described research whose primary findings could be regarded as controversial, objectionable, or potentially stigmatizing in their interpretation. Conclusions: We conclude that potential risks to participants and communities cannot be wholly eliminated by anonymization of individual data and suggest that explicit review of proposed secondary uses, by a Data Access Committee or similar internal oversight body with suitable stakeholder representation, should be a required component of the trustworthy governance of any repository of data or specimens. (shrink)

This paper seeks to challenge the “fixed line” between disciplines by exploring the interconnections of Sociology and Caribbean Literature. It highlights the Caribbean author as a social activist and policymaker whose aim is to agitate for improvement in various social conditions. The writings of three Caribbean authors—Erna Brodber of Jamaica, as well Frank McField and Roy Bodden of the Cayman Islands—are examined. Through their published and unpublished works, through their fiction and non-fiction, the interconnection between Sociology and Caribbean Literature is (...) explored. Their writings become alternative narratives that address various sociological issues, as the writers are lauded for their social activism which gave a small community in Jamaica its history and which pleads for the youth and agitates for education in the Cayman Islands. These writers, some of whom are trained sociologists, use their training and knowledge in this field and their expertise in creative writing to demonstrate that the lines of demarcation between the disciplines are becoming increasingly blurred. The paper concludes that this fusing of the disciplines means Caribbean authors can be viewed as social activists and policymakers whose works posit new thoughts and present new possibilities to ailing Jamaica and Cayman societies. (shrink)

The American Journal of Bioethics, Volume 12, Issue 10, Page 9-10, October 2012.

mHealth devices and applications, with their wide accessibility and ease of use, have the potential to address persistent inequities in biomedical research participation. Yet, while mHealth technologies may facilitate more inclusive research participation, negative features of some unregulated use in research — misleading enrollment practices, the promotion of secondary mHealth applications, discriminatory profiling, and poorer quality feedback due to dependencies on biased data and algorithms — may threaten the trust and engagement of underrepresented individuals and communities. To maximize the participation (...) of currently disenfranchised groups, those involved in unregulated mHealth research must become aware of potential risks, adopt targeted education policies, audit algorithms for hidden biases, and engage citizen scientists and other community members to identify and forestall possible harms. (shrink)

Different types of consent are used to obtain human biospecimens for future research. This variation has resulted in confusion regarding what research is permitted, inadvertent constraints on future research, and research proceeding without consent. The National Institutes of Health Clinical Center's Department of Bioethics held a workshop to consider the ethical acceptability of addressing these concerns by using broad consent for future research on stored biospecimens. Multiple bioethics scholars, who have written on these issues, discussed the reasons for consent, the (...) range of consent strategies, and gaps in our understanding, and concluded with a proposal for broad initial consent coupled with oversight and, when feasible, ongoing provision of information to donors. This article describes areas of agreement and areas that need more research and dialogue. Given recent proposed changes to the Common Rule, and new guidance regarding storing and sharing data and samples, this is an important and tim.. (shrink)

Neither the range of potential results from genomic research that might be returned to participants nor future uses of stored data and biospecimens can be fully predicted at the outset of a study. Informed consent procedures require clear explanations about how and by whom decisions are made and what principles and criteria apply. To ensure trustworthy research governance, there is also a need for empirical studies incorporating public input to evaluate and strengthen these processes.

Background Over the last decade, the return of results (ROR) in precision medicine research (PMR) has become increasingly routine. Calls for individual rights to research results have extended the “duty to report” from clinically useful genetic information to traits and ancestry results. ROR has thus been reframed as inherently beneficial to research participants, without a needed focus on who benefits and how. This paper addresses this gap, particularly in the context of PMR aimed at increasing participant diversity, by providing investigator (...) and researcher perspectives on and questions about the assumed value of ROR in PMR.Methods Semi-structured interviews with a purposive sample of investigators and researchers across federally funded PMR studies in three national consortia, as well as observations of study activities, focused on how PM researchers conceptualize diversity and implement inclusive practices across research stages, including navigating ROR.Results Interviewees (1) validated the value of ROR as a benefit of PMR, while others (2) questioned the benefit of clinically actionable results to individuals in the absence of sufficient resources for translating findings into health care for diverse and disadvantaged populations; (3) expressed uncertainties in applying the presumed value of ROR as a benefit for non-clinical results; and (4) and debated when the promise of the value of ROR may undermine trust in PMR, and divert efforts to return value beyond ROR.Conclusions Conceptualizations of diversity and inclusion among PM researchers and investigators raise unique ethical questions where unexamined assumptions of the value of ROR inform study recruitment efforts to enroll minoritized and under-represented populations. A lack of consideration for resources and infrastructure necessary to translate ROR into actionable information may hinder trustworthy community-research relationships. Thus, we argue for a more intentional interrogation of ROR practices as an offer of benefit and for whom. (shrink)

The informed consent process for genetic testing does not commonly address preferences regarding disclosure of results in the event of the patient's death. Adults being tested for familial colorectal cancer were asked whether they want their exome sequencing results disclosed to another person in the event of their death prior to receiving the results. Of 78 participants, 92% designated an individual and 8% declined to. Further research will help refine practices for informed consent.

_BMC Medical Ethics_ is an open access journal publishing original peer-reviewed research articles in relation to the ethical aspects of biomedical research and clinical practice, including professional choices and conduct, medical technologies, healthcare systems and health policies. _BMC __Medical Ethics _is part of the _BMC_ series which publishes subject-specific journals focused on the needs of individual research communities across all areas of biology and medicine. We do not make editorial decisions on the basis of the interest of a study or (...) its likely impact. Studies must be scientifically valid; for research articles this includes a scientifically sound research question, the use of suitable methods and analysis, and following community-agreed standards relevant to the research field. Specific criteria for other article types can be found in the submission guidelines. _BMC series - open, inclusive and trusted_. (shrink)

Background: The factors influencing parents’ willingness to enroll their children in biobanks are poorly understood. This study sought to assess parents’ willingness to enroll their children, and their perceived benefits, concerns, and information needs under different consent and data-sharing scenarios, and to identify factors associated with willingness. Methods: This large, experimental survey of patients at the 11 eMERGE Network sites used a disproportionate stratified sampling scheme to enrich the sample with historically underrepresented groups. Participants were randomized to receive one of (...) three consent and data-sharing scenarios. Results: In total, 90,000 surveys were mailed and 13,000 individuals responded (15.8% response rate). 5737 respondents were parents of minor children. Overall, 55% (95% confidence interval 50–59%) of parents were willing to enroll their youngest minor child in a hypothetical biobank; willingness did not differ between consent and data-sharing scenarios. Lower educational attainment, higher religiosity, lower trust, worries about privacy, and attitudes about benefits, concerns, and information needs were independently associated with less willingness to allow their child to participate. Of parents who were willing to participate themselves, 25% were not willing to allow their child to participate. Being willing to participate but not willing to allow one’s child to participate was independently associated with multiple factors, including race, lower educational attainment, lower annual household income, public health care insurance, and higher religiosity. Conclusions: Fifty-five percent of parents were willing to allow their youngest minor child to participate in a hypothetical biobank. Building trust, protecting privacy, and addressing attitudes may increase enrollment and diversity in pediatric biobanks. (shrink)

Background In the wake of mandates for biomedical research to increase participation by members of historically underrepresented populations, community engagement (CE) has emerged as a key intervention to help achieve this goal.Methods Using interviews, observations, and document analysis, we examine how stakeholders in precision medicine research understand and seek to put into practice ideas about who to engage, how engagement should be conducted, and what engagement is for.Results We find that ad hoc, opportunistic, and instrumental approaches to CE exacted significant (...) consequences for the time and resources devoted to engagement and the ultimate impacts it has on research. Critical differences emerged when engagement and research decisionmaking were integrated with each other versus occurring in parallel, separate parts of the study organization, and whether community members had the ability to determine which issues would be brought to them for consideration or to revise or even veto proposals made upstream based on criteria that mattered to them. CE was understood to have a range of purposes, from instrumentally facilitating recruitment and data collection, to advancing community priorities and concerns, to furthering long-term investments in relationships with and changes in communities. These choices about who to engage, what engagement activities to support, how to solicit and integrate community input into the workflow of the study, and what CE was for were often conditioned upon preexisting perceptions and upstream decisions about study goals, competing priorities, and resource availability.Conclusions Upstream choices about CE and constraints of time and resources cascade into tradeoffs that often culminated in “pantomime community engagement.” This approach can create downstream costs when engagement is experienced as improvised and sporadic. Transformations are needed for CE to be seen as a necessary scientific investment and part of the scientific process. (shrink)

We face significant challenges in the translation of basic biomedical research into meaningful improvements in patients' health, moving research from “bench to bedside.” The federal government's ne...

ABSTRACT:A wide range of research uses patterns of genetic variation to infer genetic similarity between individuals, typically referred to as genetic ancestry. This research includes inference of human demographic history, understanding the genetic architecture of traits, and predicting disease risk. Researchers are not just structuring an intellectual inquiry when using genetic ancestry, they are also creating analytical frameworks with broader societal ramifications. This essay presents an ethics framework in the spirit of virtue ethics for these researchers: rather than focus on (...) rule following, the framework is designed to build researchers’ capacities to react to the ethical dimensions of their work. The authors identify one overarching principle of intellectual freedom and responsibility, noting that freedom in all its guises comes with responsibility, and they identify and define four principles that collectively uphold researchers’ intellectual responsibility: truthfulness, justice and fairness, anti-racism, and public beneficence. Researchers should bring their practices into alignment with these principles, and to aid this, the authors name three common ways research practices infringe these principles, suggest a step-by-step process for aligning research choices with the principles, provide rules of thumb for achieving alignment, and give a worked case. The essay concludes by identifying support needed by researchers to act in accord with the proposed framework. (shrink)

In the United States, health disparities have been framed by categories of race. Racial health disparities have been documented for cardiovascular disease, cancer, diabetes, HIV/AIDS, and numerous other diseases and measures of health status. Although such disparities can be read as symptoms of disparities in healthcare access, pervasive social and economic inequities, and discrimination, some have suggested that the disparities might be due, at least in part, to biological differences based on race. Or, to be more precise, if race itself (...) has no determined biological meaning, race may nonetheless be a proxy that collects a group of individuals who share certain physiological or genotypic features that affect health. (shrink)

Background Investigative genetic genealogy (IGG) is a technique that involves uploading genotypes developed from perpetrator DNA left at a crime scene, or DNA from unidentified remains, to public genetic genealogy databases to identify genetic relatives and, through the creation of a family tree, the individual who was the source of the DNA. As policymakers demonstrate interest in regulating IGG, it is important to understand public perspectives on IGG to determine whether proposed policies are aligned with public attitudes.Methods We conducted eight (...) focus groups with members of the public (N = 72), sampled from four geographically diverse US regions, to explore general attitudes and perspectives regarding aspects of IGG practices, applications, and policies. Five major topics were explored in each focus group: when IGG should be used; who should perform IGG; how to approach consent for genetic database users; what systems of oversight should govern IGG practitioners; and whether to notify database users if their data are involved in law enforcement (LE) matching.Results Participants were supportive of IGG in most scenarios, especially for cold and violent cases. The favorable attitudes toward IGG were, however, tempered by distrust of law enforcement among some participants. All participants agreed that databases must inform users if IGG is allowed, but they did not agree on how individual database users should be allowed to opt out or whether to notify them if their data are involved in specific investigations. All participants agreed that IGG should be subject to some prescriptive guidelines, regulations, or accountability mechanisms.Conclusions These findings suggest broad public support for IGG, and interest in developing systems of accountability for its practice. Our study provides useful insight for policy makers, genomic database stewards, law enforcement, and other stakeholders in IGG’s practice, and suggests multiple directions for future research. (shrink)

Plausibly, only moral agents can bear action-demanding duties. Not all groups are moral agents. This places constraints on which groups can bear action-demanding duties. Moreover, if such duties imply ability then moral agents – of both the individual and group varieties – can only bear duties over actions they are able to perform. I tease out the implications of this for duties over group actions, and argue that groups in many instances cannot bear these duties. This is because only groups (...) with the right kind of structure – groups I call ‘collectives’ – have the agency to bear action-demanding duties. Yet neither can individuals bear these duties, assuming that individuals cannot perform group actions and that duty implies ability. This appears to leave us at a loss when assigning duties to perform some group actions. I argue we can solve this problem by assigning collectivization duties to individuals – duties to form a collective that then incurs a duty over the action. I give criteria for when individuals have collectivization duties and discuss the demands these duties place on their bearers. (shrink)

Individuals sometimes pass their duties on to collectives, which is one way in which collectives can come to have duties. The collective discharges its duties by acting through its members, which involves distributing duties back out to individuals. Individuals put duties in and get (transformed) duties out. In this paper we consider whether (and if so, to what extent) this general account can make sense of states' duties. Do some of the duties we typically take states to have come from (...) individuals having passed on certain individual duties? There are complications: states can discharge their duties by contracting fulfilment out to non-members; states seem able to dissolve the duties of non-members; and some of states' duties are not derived in this way. We demonstrate that these complicate, but do not undermine, the general account and its application to states. And the application has an interesting upshot: by asking which individuals robustly participate in this process of duty transfer-and-transformation with a given state, we can begin to get a grip on who counts as a member of that state. (shrink)

Metaethicists often specify non-naturalism in different ways: some take it to be about identity, while others take it to be about grounding. But few directly address the taxonomical question of what the best way to understand non-naturalism is. That’s the task of this paper. This isn’t a merely terminological question about how to use the term “non-naturalism”, but a substantive philosophical one about what metaphysical ideology we need to capture the pre-theoretical concerns of non-naturalists. I argue that, contrary to popular (...) opinion, non-naturalism is best characterized not in terms of identity or grounding, but in terms of essence. First, I lay out some desiderata for a good characterization of non-naturalism: it should (i) speak to and elucidate the non-naturalist’s core pre-theoretical commitments, (ii) render non-naturalism a substantive, local claim about normativity, and (iii) provide the most general characterization of the view possible (iv) in a way that best fits the spirit of paradigm non-naturalist views. I then argue that identity characterizations fail to satisfy the former two desiderata, while grounding characterizations at best don’t satisfy the latter two. So, I propose a new essence characterization of non-naturalism and argue that it does a better job of satisfying all four desiderata. Moreover, I argue that this essence characterization has important implications for both metaethical and metaphysical theorizing. (shrink)

Are obligations of collective agents—such as states, businesses, and non-profits—ever overdemanding? I argue they are not. I consider two seemingly attractive routes to collective overdemandingness: that an obligation is overdemanding on a collective just if the performance would be overdemanding for members; and that an obligation is overdemanding on a collective just if the performance would frustrate the collective’s permissible deep preferences. I reject these. Instead, collective overdemandingness complaints should be reinterpreted as complaints about inability or third-party costs. These are (...) not the same as overdemandingness. Accordingly, we can ask an awful lot of collective agents. (shrink)

Humans are powerful and clever, and also more ignorant than they know. As a result, they too often fail to acknowledge or even recognize their limitations, and are more arrogant than humble regarding their capabilities. Education that explicitly recognizes and addresses the context of science and technology, their inherent values and ethical implications and concerns, and their problematic as well as beneficial impacts can potentially rescue the human species from itself.

The Corporate Social Performance (CSP) model (Wood, Acad Manag Rev 164:691–718, 1991) assesses a firm’s social responsibility at three levels of analysis—institutional, organizational and individual—and measures the resulting social outcomes. In this paper, we focus on the individual level of CSP, manifested in the managerial discretion of a firm’s principles, processes, and policies regarding social responsibilities. Specifically, we address the human resources management of employees as a way of promoting CSR values and producing socially minded outcomes. We show that applying (...) the humanist philosophy to the managerial discretion of a business organization leads to the creation of an “autonomy supportive work environment”—as defined by the self-determination theory—which in turn, facilitates the internalization of social values, citizenship behaviors, and cooperation. The objective of promoting self-determination at work (i.e., the core of a humanist management) fits well with the ontology of social responsibility since autonomy and consideration of individuals as moral actors are central tenets. Furthermore, we show that applying humanistic management philosophy to the discretion of managers can lead to socially responsible outcomes. First, intra-organizational stakeholders (e.g., employees) are treated with respect and focus is put on their well-being, satisfaction, and self-actualization at work. Second, as employees’ need of self-determination is addressed by managers, it is likely that pro-social behaviors toward other stakeholders of the organization will be adopted, leading to socially responsible outcomes for extra-organizational stakeholders (Gagné, Motiv Emot 77:58–75, 2003). Thus, this paper ultimately posits that humanistic management applied to the HRM can be a solution for developing and maintaining socially responsible outcomes as determined at the individual level of the CSP model, through managerial discretion. (shrink)

Focusing on the U.S. military as a gendered and raced institution and using 33 in-depth interviews with U.S. servicewomen, this study identifies tactics and consequences of workplace harassment that occur through administrative channels, a phenomenon I label bureaucratic harassment. I identify bureaucratic harassment as a force by which some servicemen harass, intimidate, and control individual, as well as groups of, servicewomen through bureaucratic channels. Examples include issuing minor infractions with the intention of delaying or stopping promotions, threatening to withhold military (...) benefits for reporting sexual abuse/harassment, and revoking servicewomen’s qualifications in order to remove them from positions or units. The manipulation of administrative rules and regulations is made possible by the interplay between a gendered and raced organizational climate and bureaucratic features such as discretion, hierarchy, and the blending of work and personal life. I show that bureaucratic harassment has both raced and gendered implications. Ultimately, harassment that is enacted through bureaucratic means is often overlooked but carries distinct consequences for the professional careers and workplace experiences of the victims. (shrink)

This chapter discusses the slow burn of development which has impacted the Chinese landscape for a long time, despite the country’s urbanization. Although China’s modernization has been underway for the last 150 years, the country’s current global visibility has been mistaken for a sudden eruption of modernity. China has been through a variety of struggles, and the struggle between beauty and pragmatism is portrayed in films about the poor and manifested through the class aspirations of the new rich. In this (...) regard, the landscaping of China is mostly a narrative of continuous and traumatic pressure inflicted by the people on the motherland. These signs of struggle are, therefore, what articulate the Chinese landscape as a work of destruction and reconstruction in constant progress. (shrink)

This article explores the therapeutic potential of narrative fiction during a global health crisis. We focus on The Decameron Project, a collection of short fiction by writers from around the world, commissioned by the New York Times Magazine. The Decameron Project references the narrative framework established by Giovanni Boccaccio in the mid-14th century, when the Black Death devastated Europe. Drawing on aspects of psychoanalytic theory and principles of bibliotherapy employed since the Middle Ages, we argue that The Decameron Project offers (...) strategies to simultaneously confront and contain the anxious mind. Storytelling, according to both Boccaccio and to the editors of The Decameron Project, is not merely a source of distraction but a means of survival. (shrink)

Pharmaceutical memory modification is the use of a drug to dampen, or eliminate completely, memories of traumatic experience. While standard therapeutic treatments, even those including intense pharmaceuticals, can potentially offer individual biomedical healing, they are missing an essential perspective offered by Christian bioethics: re/incorporation of individuals and traumatic memories into communities that confront and reinterpret suffering. This paper is specifically grounded in Christian ethics, engaging womanist understandings of Incarnational, embodied personhood, and Johann Baptist Metz’s “dangerous memory.” It develops an ethical (...) framework of Christian “enfleshed counter-memory” that responds to the specific challenge of pharmaceutical memory modification, and traumatic experience generally. (shrink)

This paper provides an overview of Group Duties: Their Existence and Their Implications for Individuals.

This is a response to the critial comments by Anne Schwenkenbecher, Olle Blomberg, Bill Wringe and Gunnar Björnsson.

Some contemporary states are morally culpable for historically distant wrongs. But which states for which wrongs? The answer is not obvious, due to secessions, unions, and the formation of new states in the time since the wrongs occurred. This paper develops a framework for answering the question. The argument begins by outlining a picture of states’ agency on which states’ culpability is distinct from the culpability of states’ members. It then outlines, and rejects, a plausible-seeming answer to our question: that (...) culpability transmits from a past state’s action to a present state just if the two states share a numerical identity, for example as determined by international law. I advocate a different answer: culpability transmits from a past action to a present state to the extent that the present state ‘descends from’ the aspects of the past state that underpinned the past action. One potential upshot is that some present-day settler-colonies (such as Australia) are culpable for the centuries-ago invasion of their lands by European powers—even though these states did not perform these invasions and indeed did not exist at the time. (shrink)

This article discusses the Tang Wei incident, which evolved across the first half of 2008, during the run-up to the Olympic Games in Beijing. Tang Wei is a Chinese actress whose breakthrough role in Ang Lee’s film Lust, Caution caused a sensation amongst Chinese audiences. The nudity and sex scenes in the film were explicit, and as such challenged accepted norms in film content. This aspect of the film, combined with the characterization of a national traitor as a heroine, caused (...) deep concern among some parties involved in film regulation and censorship. The argument presented here is that Tang Wei, who was singled out for criticism and upon whom travel and work restraints were placed in the aftermath of the film’s release, was made a scapegoat for the disgust experienced by a masculinist political class when faced with female dissent and sexuality. (shrink)

When we say that ‘the government should be ashamed’, can we be taken literally? I argue that we can: organisations have duties over their emotions. Emotions have both functional and felt components. Often, emotions’ moral value derives from their functional components: from what they cause and what causes them. In these cases, organisations can have emotional duties in the same way that they can have duties to act. However, emotions’ value partly derives from their felt components. Organisations lack feelings, but (...) can have duties to increase the likelihood that their members have relevant emotions (with the right felt components), in virtue of and in accordance with their role in the organisation. To systematise these conclusions, I provide a taxonomy of organisations’ – and individuals’ organisationally situated – emotional duties. This taxonomy will enable scholars of electoral politics, international politics and public policy to systematically integrate emotions into the study of organisations. (shrink)